Overview
A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment
Status:
Completed
Completed
Trial end date:
2009-07-01
2009-07-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
This study is designed to determine the effects of a single dose of the study medication in subjects with and without hepatic impairment. 18 to 24 subjects will participate by having multiple blood draws taken to measure the level of study medication in their blood over time.Phase:
Phase 1Accepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
VIVUS, Inc.Collaborators:
Covance
SentrxTreatments:
Phentermine
Topiramate
Criteria
Inclusion Criteria:A total of 18 to 24 subjects will be studied in 3 groups of 6-8 subjects per group. Group 1
will consist of 6-8 males or females with normal hepatic function, 18 to 65 years of age
inclusive. Groups 2-3 will consist of 6-8 males or females per group with varying degree of
stable hepatic impairment.
Exclusion Criteria:
Any Subject meeting the following criteria must be excluded from the trial:
1. Known history of clinically significant arrhythmias.
2. Acute illness, especially any infection, within 2 weeks of dosing.
3. History or presence of:
- Alcoholism or drug abuse within the past 2 years.
- Hypersensitivity or idiosyncratic reaction to compounds related to the study drug
or related compounds.
4. Any History of Bipolar disorder or psychosis, history of psychiatric hospitalization,
greater than one lifetime episode of major depression.
5. Blood donation or significant blood loss within 56 days prior to Day 1.
6. Plasma donation within 7 days prior to Day 1.
7. Any subject who has participated in a previous clinical trial with VI-0521.
8. Any subject who received an investigational drug within 30 days prior to dosing in
this study.
9. Any history of glaucoma, increased intraocular pressure, or medications to treat
increased intraocular pressure.
10. Serum creatinine > 1.5 for male subjects, and >1.4 for female subjects.
11. History of kidney stones in the last 6 months
12. Female subjects, who may be pregnant, or are lactating.
13. Use of any drug that is known to have clinical significance in inhibiting or inducing
liver enzymes involved in drug metabolism.
14. Use of tobacco or nicotine products within last 6 months unless subject is
hepatically-impaired.